The lot release of human vaccines by the South African National Control Laboratory for Biological
Products are performed within the framework of the Medicines and Related Substances Act, 1965 (Act
No. 101 of 1965) as amended and Act 14 of 2015, regulations 15(1) and 15(2).
This guideline should be read together with the latest National Control Laboratory (NCL) circular on
General Information Regarding Vaccines and Lot Release, which is available on request at